ABSTRACT
OBJECTIVE: In the last decade, data published stressed the role of highly-sensitive thyroglobulin (Tg) assays in the follow-up of differentiated thyroid carcinoma (DTC) patients. The present study describes a new, highly-sensitive Tg assay, compares it with an available commercial assay, and validates it in the follow-up of DTC patients. SUBJECTS AND METHODS: The immunofluorometric high-sensitivity Tg assay is based on monoclonal and polyclonal antibodies produced at our laboratories. It was validated in 100 samples of 87 patients with DTC submitted to total thyroidectomy, 87% of whom also received radioiodine. For correlation, all samples were also tested using a commercial Tg assay (Beckman Access) with functional sensitivity (FS) of 0.1 ng/mL. RESULTS: The new method showed FS of 0.3 ng/mL. The correlation between the two methods was good (r = 0.74; p < 0.0001). The diagnostic sensitivity was 88.9%, and it was increased to 100% when combined with neck US. CONCLUSION: This new, high-sensitivity Tg assay presented a good correlation with Beckman Access assay and with the clinical outcome of the patients. The continuous availability of a validated assay is an additional advantage for long term follow-up of DTC patients. Arq Bras Endocrinol Metab. 2012;56(9):658-65.
OBJETIVO: Na última década, estudos mostraram a importância dos ensaios de tiroglobulina (Tg) com melhor sensibilidade funcional no seguimento dos pacientes com carcinoma diferenciado de tiroide (CDT). Neste estudo, descrevemos o desenvolvimento de um novo ensaio de Tg de alta sensibilidade, que foi validado no seguimento de pacientes com CDT e correlacionado com um ensaio comercialmente disponível. SUJEITOS E MÉTODOS: O ensaio imunofluorométrico de Tg baseia-se em anticorpos, um monoclonal e um policlonal desenvolvidos em nosso laboratório. Avaliamos 100 amostras de soro de 87 pacientes com CDT submetidos à tiroidectomia total, sendo que 87% deles também receberam 131I. A Tg foi dosada também em ensaio comercial (Beckman Access). RESULTADOS: A correlação entre os dois métodos foi de 0,74 (p < 0,0001). O novo ensaio mostrou uma sensibilidade funcional de 0,3 ng/mL. A sensibilidade diagnóstica foi de 88,9%, que aumentou para 100% quando associada ao ultrassom cervical (US). CONCLUSÃO: O novo método de dosagem de Tg mostra boa correlação com o ensaio comercial Beckman Access e com a evolução clínica dos pacientes. O novo ensaio será fundamental no seguimento dos nossos pacientes com CDT. Arq Bras Endocrinol Metab. 2012;56(9):658-65.
Subject(s)
Adult , Aged , Animals , Female , Humans , Male , Mice , Middle Aged , Rabbits , Young Adult , Fluoroimmunoassay/standards , Thyroglobulin/blood , Antibodies, Monoclonal/biosynthesis , Antibodies, Monoclonal , Fluoroimmunoassay/methods , Sensitivity and Specificity , Thyroid Neoplasms/diagnosisABSTRACT
As viral vaccines sometimes induce the side effects which intimidate humans, it is urgently required to study about the side effects of viral vaccines. Most vaccines are derived from the biological forms. Hence it should be established the efficient and sensitive evaluation methods for the possibility of dangerous contaminants such as viruses and the stability of vaccines. A lots of vaccine products have been imported, or in sale or being developed in nation. Some of products may be mixed with the hazardous viruses derived from animal or human resources. Such hazardous viruses should be identified specifically and efficiently. Biological products are not permitted to distribute or obtain without presenting the result of absence experiment of hazardous viruses and prion and the validation data of inactivation experiment during processes. In order to detect viruses, there were TEM for viral particles, infectivity assays and detection methods for nucleic acids. However, these methods have defects such as insensitivity and inaccuracy. It should be considered to detect only the hazardous viruses with specificity, precision and accuracy during the processes of preparation, transportation and storage. It is noted to increase the detection limit in order to detect the minute hazardous factors during preparation processes for viral vaccines. This study is focused on the establishment of various sensitive PCR/ELISA methods for HBV virus which enhance the detection limit in order to detect the minute hazardous factors during preparation processes for viral vaccines.